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- FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for PatientsThe U.S. Food and Drug Administration (FDA) today issued draft guidance to help developers bring promising gene therapies to patients more efficiently by making greater use of existing scientific a…fda press · 1mo ago↗ source
- FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer DrugsThe U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs.fda press · 2mo ago↗ source
- FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) InfectionToday, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarr…